Recall Z-0239-04 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Drug Free Enterprises Inc
DrugCheck 5, in-vitro diagnostic test for drugs of abuse: AMP, COC, THC, OPI, MET.
| Date | Dec 18, 2003 (initiated Mar 20, 2003) |
| Status | Terminated |
| Reason | Lacks professional use labeling and firm name and address. |
| Root cause | Other |
| Action | Firm sent letters and stickers to customers in April 2003 asking them to overlabel existing stocks and to tell the firm how many were overlabeled. Recall is complete. |
| Quantity | 2800 units |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.